CSA C22.2 NO. 80601-2-30:19:2019 Edition
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Medical electrical equipment – Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
| Published By | Publication Date | Number of Pages |
| CSA | 2019-09-01 | 147 |
CSA Preface
This is the second edition of CSA C22.2 No. 80601-2-30, Medical electrical equipment — Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 80601-2-30 (second edition, 2018-03). It supersedes the previous edition, published in 2010 as CAN/CSA-C22.2 No. 80601-2-30 (adopted IEC 80601-2-30:2009). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code.
For brevity, this Standard will be referred to as CSA C22.2 No. 80601-2-30 throughout.
This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:14, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (adopted IEC 60601-1:2005, including Amendment 1:2012, with Canadian deviations).
This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.
Scope and object
Clause 1 of the general standard2 applies, except as follows:
201.1.1 Scope
Replacement:
This part of the 80601 International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of AUTOMATED SPHYGMOMANOMETERS, hereafter referred to as ME EQUIPMENT, which by means of an inflatable CUFF, are used for non-continuous indirect estimation of the BLOOD PRESSURE without arterial puncture.
NOTE 1 Equipment that performs indirect DETERMINATION of the BLOOD PRESSURE without arterial puncture does not directly measure the BLOOD PRESSURE. It only estimates the BLOOD PRESSURE.
This document specifies requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE for this ME EQUIPMENT and its ACCESSORIES, including the requirements for the accuracy of a DETERMINATION.
This document covers automatic electrically-powered ME EQUIPMENT used for the intermittent, indirect estimation of the BLOOD PRESSURE without arterial puncture, including BLOOD PRESSURE monitors for the HOME HEALTHCARE ENVIRONMENT.
Requirements for indirect estimation of the BLOOD PRESSURE without arterial puncture ME EQUIPMENT with an electrically-powered PRESSURE TRANSDUCER and/or displays used in conjunction with a stethoscope or other manual methods for determining BLOOD PRESSURE (NON-AUTOMATED SPHYGMOMANOMETERS) are specified in document ISO 81060-1 [2].
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 201.11 and 201.105.3.3, as well as 7.2.13 and 8.4.1 of IEC 60601-1:2005.
NOTE 2 See also 4.2 of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for an AUTOMATED SPHYGMOMANOMETER as defined in 201.3.201.
